CDSCO directs states DCs to accept hard copy of application from medical devices traders for registration certificate

New Delhi, November 1, 2022:

The Central Drugs Standard Control Organisation (CDSCO) has directed all the state drug controllers (DCs) to accept the hard copy of the application to issue Registration Certificates to trade medical devices including in vitro diagnostic medical devices, which has been announced by the Union health ministry as an alternative to drugs sale license for these devices.

The Drugs Controller General (India), Dr V G Somani, in a notice recently said that the CDSCO has received various representations from the stakeholders, regarding implementation of the Medical Devices (Fifth Amendment) Rules, 2022, which was notified on September 30, 2022, stating that their application in hard copy is not being accepted by the State Licensing Authority (SLA) for registration.

As per the amended rules, the applicant may apply for grant of Registration Certificate in Form MD-41 to the concerned SLA and the SLA after satisfying the requirements shall issue Registration Certificate in Form MD-42 to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device in the country.

“Accordingly, all the SLAs are requested to accept the applications in hard copy from such applicants of medical devices and dispose off the application expeditiously on priority and also to ensure uninterrupted access/supply of such medical devices,” said Somani in the notice.

The Medical Devices (Fifth Amendment) Rules, 2022, added a provision for Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device, including in vitro diagnostic medical device, as alternative to Drugs Sale License, with effect from September 30, 2022.

In Medical Devices Rules, 2017, in rule 34 which is on the procedure to apply for grant of import licence where eligibility for application is provided for an authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution, the MoHFW has inserted the provision so that for those who have registration certificate in Form MD-42 also to apply for the import license.

Similarly, in the Rule 87, which deals with the provisions for sale of medical devices, a sub rule has been inserted to mandate that any person not holding license under Sub-Rule (1) and intends to sell medical devices exclusively as referred to in clause (zb) of Rule 3 (which include in vitro diagnostic and surgical dressing, contraceptives, among others), shall obtain registration certificate as provided in these Rules.

It mandated that the State Licensing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificates for such specific areas. Those who want to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical devices, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate for the same with specific certificates and documents.

It also specifies the conditions of registration certificate for sales or distribution of medical devices, which mandates that the registration certificate should be displayed at a prominent place in the premises visible to the public, the certificate holder shall provide adequate space and proper storage condition for storage of the medical devices, shall maintain requisite temperature and lighting as per requirements of such medical devices, and the medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity, among others.Pharmabiz